PLC Systems Inc. (Amex: PLC) reported that it has discussed the results of its pilot safety study of the RenalGuard System(TM) and Therapy with the U.S. Food and Drug Administration. Based upon the positive safety goods already collected in the pilot study and its discussions with FDA, PLC has stopped enrolling new patients in the pilot study and will submit a demand to transition into a new pivotal trial protocol.

The pilot trial was originally designed as a safety study for up to 40 patients; PLC has successfully enrolled and treated 23 patients in the pilot study at five approved sites to term. The company concluded that finishing the total planned enrollment was now unnecessary based upon the initial review of safety documents already obtained.

Mark R. Tauscher, president and chief executive officer of PLC Systems, said, “We are very pleased with the successful early conclusion to our pilot

safety trial. that enables us to move forward expeditiously with our planned pivotal trial for that innovative therapy. Our pivotal trial is expected to be a multi-center, randomized controlled study designed to demonstrate that RenalGuard is effective in reducing the incidence of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing cardiovascular imaging procedures. The results from that pivotal trial will be used to support the regulatory approval process needed to market RenalGuard as a CIN prevention device. We expect to enroll patients at up to 30 sites all through the country in that trial.”

He added, “With the number of cardiovascular imaging procedures expected to grow in the future and more patients being deemed at risk of CIN due to underlying health conditions, we believe the need for a product such as RenalGuard is more critical than ever in preventing that expensive and potentially life threatening condition.”

Original post by Mallows